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NCT Number: NCT04165369

Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospitals, Al Mansurah, Egypt

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About this study

Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors.

Method: International prospective, observational, multi-center, cross-sectional cohort study

Eligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • major elective or emergency surgery procedures with a duration of at least 2 h
  • admission to the intensive care unit, intermediate care unit after surgery informed consent

Exclusion criteria

  • preexisting acute kidney injury
  • acute kidney injury within the last 3 months
  • end stage renal disease with dialysis dependency
  • kidney transplant

Treatment and study plan

Primary outcomes

  1. Incidence of Acute Kidney Injury

    Time frame: 72 hours after extended surgery

    Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Secondary outcomes

  1. Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)

    Time frame: 72 hours after extended surgery

    Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury

  2. Number of patients with renal replacement therapy

    Time frame: up to 90 days after extended surgery

  3. Mortality

    Time frame: up to 90 days after extended surgery

  4. Hospital stay

    Time frame: up to 90 days after extended surgery (until discharge)

  5. Intensive Care Unit stay

    Time frame: up to 90 days after extended surgery (until discharge)

  6. Major Adverse Kidney Events (MAKE)

    Time frame: up to 90 days after extended surgery

    combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine >= 1.5 times as compared to baseline serum-creatinine

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: Epis-AKI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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